Destiny Pharma invited to present at the inaugural Superbugs & Superdrugs USA Conference & Exhibition on the 14th and 15th November 2016 in New Jersey, USA

Destiny Pharma has been invited to present at the inaugural Superbugs & Superdrugs USA Conference & Exhibition on the 14th and 15th November 2016 in New Jersey, USA. The conference will include international speakers on the hot topics – superbug/superdrug defence strategy, funding opportunities, updates on R&D projects and look to define a risk mitigation plan to prevent global superbug outbreaks. Please contact us on conferences@destinypharma.com if you would like to arrange a meeting during Superbugs & Superdrugs USA.

Destiny Pharma Welcomes O’Neill Report on Tackling Antimicrobial Resistance (AMR)

Final report of Government’s AMR Review calls for $1 billion reward for new drugs.

Adoption of this and other recommendations is on the G7, G20 & United Nations main agendas in May and September this year.

Destiny Pharma’s XF drugs are a novel antibacterial approach, with a rapid bacterial kill and the capability to address AMR, and are already in advanced clinical development in the UK & US

Brighton, UK, 19 May 2016: – Destiny Pharma Ltd, a leading clinical stage pharmaceutical company focused on developing antibacterial medicines, is pleased to welcome and applaud the final report and recommendations of the UK Review on Antimicrobial Resistance (AMR Review) chaired by Lord O’Neill.

In July 2014, the UK Government commissioned the Review on Antimicrobial Resistance in collaboration with the Wellcome Trust. The Review is independent and engages widely with international stakeholders to understand and propose solutions to the problem of antimicrobial resistance, from an economic and social perspective and outlines 10 areas where the world needs to take action to tackle AMR. Many of these measures focus on reduction of antibiotic resistant infections, incentivising industry to develop much needed new drugs and infection prevention approaches.

Dr Bill Love, CEO of Destiny Pharma commented:Antibiotic resistance is a recognised global threat. If not addressed, it is predicted to have a greater impact than cancer, a $100 trillion annual global cost and is the harbinger of the end of modern medicine as we know it. We welcome the final report and recommendations of the Review of Antimicrobial Resistance. Addressing the lack of development of new antibiotics, and the urgent need for novel antibacterial drugs – ideally ones which counter bacterial drug resistance – is of paramount importance”.

There has been an absence of big pharma in the development of antibiotics – smaller, independent companies like Destiny Pharma have driven innovation in recent years and have products close to market. The proposal for Market Entry Rewards as outlined in the O’Neill report potentially rewarding companies with a $1 billion payment upon new drug approval, would be a shot in the arm for developing much needed new drugs. The report also recommends a Play or Pay levy on big pharma to help fund new products, which is offset if they already develop drugs in this area. Adoption and implementation of the report recommendations is estimated to cost $4 billion a year, a fraction (0.05%) of the G20’s spend on healthcare and a small price to pay to address this global crisis. Political consensus will be crucial in delivering these recommendations and we look forward to the discussions at the forthcoming global forums, including the G7, G20 and for the first time AMR is on the high level agenda of United Nations General Assembly meeting.

One of Destiny Pharma’s XF drug product developments is an antibacterial drug that tackles the prevention of post-surgical bacterial infection, including antibiotic resistant bacteria – a major cause of hospital infection. The lead drug candidate XF-73, has completed 4 clinical studies in the UK and shown to reduce the number of bacteria rapidly, with a US clinical trial to be reported shortly. In laboratory tests XF-73 has been shown not to succumb to bacterial resistance – unlike traditional antibiotics. XF-73 was granted Qualifying Infectious Disease Product (QIDP) status in October 2015 by the FDA for a new US indication for the, ‘Prevention of post-surgical staphylococcal infections’.

Dr Bill Love added:At Destiny Pharma our innovative drug development has already produced the revolutionary XF drug series. Evidence shows that the likelihood of bacterial resistance developing to these drugs is remote – offering a totally new means to prevent and treat certain bacterial infections. The stimulus of the AMR Report recommendations will assist us to achieve our goal of a new range of novel antimicrobial drug products.”

For further information please contact:
Hume Brophy
Mary Clark, Eva Haas, Hollie Vile
Tel: +44 20 3440 5813
Email: destinypharma@humebrophy.com

About Destiny Pharma:
Destiny Pharma, a leading, clinical stage biopharmaceutical company, founded in 1997. The Company focuses on the R&D of new antimicrobial drugs, with an emphasis on novel mechanisms of action that seek to address the global healthcare issue, namely, Antibiotic Resistance. Exeporfinium chloride is the Company’s lead drug which has completed 4 Phase I/IIa clinical studies in the UK/Europe. Through its extensive business network and strategic partnerships, Destiny Pharma intends to globally commercialize candidates from the XF Drug platform based on dicationic porphyrins which are differentiated from traditional antibiotics structurally. XF drug candidates are able to kill static and growing bacterial cultures, as well as bacteria with biofilm and may thus see limited resistance development. Non-growing cultures often become resistant to traditional antibiotics that rely on the bacteria actively growing to kill them. Additional information on Destiny Pharma is available at www.destinypharma.com.

About infections and hospital admissions:
Infection remains a major complication for hospital admissions. The
most common cause of infection is the bacteria Staphylococcus aureus
(SA), including the antibiotic resistant form, MRSA. Infection prevention
measures including decolonisation of SA/MRSA ahead of surgery in at-risk
patients are now practised in many countries, but the continuing problem
of bacterial resistance prevents the procedure being extended to the
larger number of patients who could benefit. There is an urgent global
need for drugs that can effectively prevent SA infections in patients
without succumbing to bacterial resistance. In the USA alone it is estimated
drug-resistant forms of SA such as MRSA result in 19,000 deaths per
year. The annual cost of Staphylococcus aureus infection in the
US is put at $9.5 billion.

A report in The Lancet 15th October 2015, estimates that between
38 – 51% of bacteria that cause post-surgical infections are resistant
to traditional antibiotics used and that a 30% reduction in current
antibiotic effectiveness could result in 120,000 additional post-surgical
and chemotherapy related infections in the USA alone.

Forward Looking Statement:
This press release contains forward-looking statements that are subject to risks and uncertainties and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Destiny Pharma disclaims any intent or obligation to update forward-looking statements except as required by law.

Destiny Pharma: ‘In the News.’

Following the recent media coverage of the Declaration, co-signed by Destiny Pharma, calling on governments to work with them to develop new and alternative market structures that provide more dependable and sustainable market models for antibiotics, and to commit the funds needed to implement them, interviews with Dr Bill Love, CEO of Destiny Pharma have appeared in a number of recent publications. Interviewed in SCRIP Intelligence, the leading source of news and strategic analysis for the global pharmaceutical industry, Dr Love outlined the current clinical development status of XF-73 (exeporfinium chloride), Destiny Pharma’s lead product, in the US. With the completion in the coming weeks of a clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), studying Staphylococcus aureus (SA) decolonization (i.e. the clearance of SA from the nostrils of carriers) as well as safety and tolerability, and the recent Qualified Infectious Disease Product Designation Granted to XF-73 by the FDA for Novel Antibacterial Product In Development for Prevention of Post-Surgical Staphylococcal Infections, the article noted that Destiny Pharma has “placed itself firmly on the radar in the US”. In a further interview with EP Vantage, Dr Love detailed the unique properties that XF-73 has which make it ideally placed to become the drug of choice for the prevention of post-surgical Staphylococcal infections once it is approved. Dr Love also outlined the need for new antibacterial drugs to combat the issue of resistance, and how government incentives such as the US GAIN (Generating Antibiotic Incentives Now) Actare stimulating the research focus on developing new antibacterial drugs. For further information about Destiny Pharma or to arrange an interview with Dr Love, please contact: destinypharma@humebrophy.com.

Destiny Pharma sign Declaration to fight antibiotic resistance

Destiny Pharma has joined other pharmaceutical companies. including GlaxoSmithKline, Merck , Pfizer, Sanofi, Novartis and AstraZeneca, in calling on governments to work with them to develop new and alternative market structures that provide more dependable and sustainable market models for antibiotics, and to commit the funds needed to implement them. The Declaration, by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance was launched at the World Economic Forum in Davos, Switzerland last week. The Declaration was drafted, agreed and signed by 85 companies and nine industry associations from across the global pharmaceutical, diagnostics and biotechnology industries in 18 different countries. The statement sets out for the first time how governments and industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance. Dr Bill Love, CEO of Destiny Pharma said “We welcome the publication of this Declaration, which demonstrates the need for a coordinated plan at a governmental level to tackle the issue of antibiotic resistance”.

Press Release: Destiny Pharma Announces Qualified Infectious Disease Product Designation Granted by US FDA for Novel Antibacterial Product In Development for Prevention of Post-Surgical Staphyloccocal Infections

11th November 2015, Brighton, UKDestiny
Pharma Ltd,
a leading, clinical stage biopharmaceutical companyfocused
on developing and commercialising antibacterial drug products, today
announced that the US Food and Drug Administration (FDA) has granted
Qualified Infectious Disease Product (QIDP) designation to Destiny Pharma’s
lead drug product candidate, XF-73, (Exeporfinium chloride). This is
a novel, synthetic drug with anti-bacterial activity against a broad
range of bacteria. The drug is being developed against the bacteria,
Staphylococcus aureus, including the multi-antibiotic resistant
strain, Methicillin-Resistant Staphylococcus aureus, (MRSA).

The QIDP designation for XF-73 is for the prevention of post-surgical
Staphylococcal infections and there are tens of millions of patients
entering hospitals each year who are at significant risk of contracting
a post-surgical infection because they ‘carry’ this bacteria. Under
the GAIN (Generating Antibiotic Incentives Now) Act, QIDP status confers
FDA priority review, eligibility for fast-track status and an additional
five-year extension of US patent exclusivity when approval is granted.

The FDA grants QIDP designations to drugs intended to treat serious
or life-threatening infections, caused by “qualified pathogens”. These
pathogens include the hospital Superbug, MRSA, one of the leading causes
of post-surgical infections.

Data from four Phase I/IIa studies in Europe has shown that XF-73 is
rapidly bactericidal i.e. reducing the number of bacteria in the nose
quickly. Coupled with the unique property to prevent bacterial resistance
demonstrated in laboratory tests (1), XF-73 promises to be able to prevent
potentially fatal Staphylococcus aureus infections. An approach
which is becoming compromised due to a limited number of antibiotics
and antibiotic resistance. In the USA, a clinical trial of XF-73 is
sponsored and funded by the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH), and
is expected to complete shortly.

Dr Bill Love, CEO of Destiny Pharma, commented: “The QIDP designation
is an important milestone in the development of our lead product XF-73
which represents a new approach in hospital infection prevention for
millions of surgical patients. Around the world, governments and global
organisations are calling for new anti-bacterial drugs and are introducing
incentives to reward companies for delivering these products. Tackling
Antibiotic Resistance is on the G7 agenda and industry is starting to
return to this space. XF-73 has a novel bacterial-killing action which
offers the potential of a more comprehensive surgical infection prevention
program.”

For further information please contact:
Hume Brophy
Mary Clark, Eva Haas, Hollie Vile
Tel: +44 20 3440 5813
Email: destinypharma@humebrophy.com

About Destiny Pharma:
Destiny Pharma, a clinical stage biopharmaceutical company, was founded
in 1997. The Company focuses on the R&D of new antimicrobial drugs,
with an emphasis on novel mechanisms of action that seek to address
the global healthcare issue, namely, Antibiotic Resistance. XF-73 is
the Company’s lead drug which has completed 4 Phase I/IIa clinical studies
in the UK/Europe. Through its extensive business network and strategic
partnerships, Destiny Pharma intends to globally commercialise candidates
from the XF Drug platform based on dicationic porphyrins which are differentiated
from traditional antibiotics structurally. XF drug candidates are able
to kill static and growing bacterial cultures, as well as bacteria with
biofilm and may thus see limited resistance development. Non-growing
cultures often become resistant to traditional antibiotics that rely
on the bacteria actively growing to kill them. Additional information
on Destiny Pharma is available at www.destinypharma.com

About infections and hospital admissions:
Infection remains a major complication for hospital admissions. The
most common cause of infection is the bacteria Staphylococcus aureus
(SA), including the antibiotic resistant form, MRSA. Infection prevention
measures including decolonisation of SA/MRSA ahead of surgery in at-risk
patients are now practised in many countries, but the continuing problem
of bacterial resistance prevents the procedure being extended to the
larger number of patients who could benefit. There is an urgent global
need for drugs that can effectively prevent SA infections in patients
without succumbing to bacterial resistance. In the USA alone it is estimated
drug-resistant forms of SA such as MRSA result in 19,000 deaths per
year. The annual cost of Staphylococcus aureus infection in the
US is put at $9.5 billion.

A report in The Lancet 15th October 2015 (2), estimates that between
38 – 51% of bacteria that cause post-surgical infections are resistant
to traditional antibiotics used and that a 30% reduction in current
antibiotic effectiveness could result in 120,000 additional post-surgical
and chemotherapy related infections in the USA alone.

References:
1. David Farrell et al., “Investigation of the potential for
mutational resistance to XF-73, Retapamulin, Mupirocin, Daptomycin,
Fusidic acid & Vancomycin in MRSA isolates during a 55 passage study”.
Antimicrob.Agents & Chemo., (2011), p1177
2. Aude Teillant et al., “Potential burden of antibiotic resistance
on surgery and cancer chemotherapy antibiotic prophylaxis in the USA:
a literature review and modelling study.”, The Lancet Online, 15th Oct
2015. http://dx.doi.org/10.1016/S1473-3099(15)00270-4

Forward Looking Statement:
This press release contains forward-looking statements that are subject
to risks and uncertainties and includes statements that are not historical
facts. Actual results could differ significantly from results discussed.
Destiny Pharma disclaims any intent or obligation to update forward-looking
statements except as required by law.

G7 Health Minsters committed to tackle antimicrobial resistance

The health ministers from United States, Canada, Japan, France, Germany, Italy and the United Kingdom have announced that they are committed to take action to tackle the problem of antimicrobial resistance (AMR) at the G7 meeting in Berlin, Germany. The G7 health ministers agreed on a number of actions to implement the G7 Leaders Declaration as outlined in the “Berlin Declaration on AMR” The health ministers acknowledged that the emergence of AMR is an increasing global health threat and that infection with AMR pathogens leads to prolonged treatment times, higher mortality, heavy burdens on health systems and high economic impacts. The impact of AMR was put as 700,000 deaths may be caused each year globally by resistant pathogens and compared to a world where AMR did not exist, current AMR rates may cause a GDP contraction in OECD countries which by 2050 would result in cumulative losses of approximately US$2.9 trillion.
One of the three key approaches identified by the health ministers is to engage in research to optimise such approaches and to develop new antimicrobials, vaccines, treatment alternatives and rapid diagnostic tools and called for the strengthening and encouraging of increased R&D of new antimicrobial compounds. The health ministers also stated that they are committed to explore innovative economic incentives to enhance the R&D of new antimicrobial compounds, looking at various instruments such as a global antibiotic research fund and a market entry reward mechanism for truly new antibiotics targeting the most important pathogens.

BEAM (Biotechs from Europe innovating in Anti-Microbial resistance) Alliance release first position paper identifying the key actions required to reinvigorate investment and R&D in the antibacterial field

The BEAM (Biotechs from Europe innovating in Anti-Microbial resistance) Alliance, of which Destiny Pharma is a founding member, has released their first position paper entitled “Key Actions to Reinvigorate Investment and R&D in the antibacterial field Now” The paper urges European and National public authorities to take three key short term complementary actions with immediate effect:

1. Create a specific fund dedicated to small and medium biopharmas to finance projects from discovery to clinical proof of concept

2. Enhance market incentives to increase the attractiveness of developing new products tackling antimicrobial resistance

3. Strengthen the existing actions of the European Medicines Agency
(EMA) to accelerate and simplify the regulatory pathways for products
tackling antimicrobial resistance

The position paper also provides
some food for thought on longer-term perspectives to strengthen and
increase the R&D into new antibacterial drugs. Dr Bill Love, CEO of
Destiny Pharma said “The actions identified in the BEAM position paper
are intended to stimulate much needed investment into the development
of new antibacterial drugs. Europe needs to follow the USA, where positive
actions are being taken to incentivise companies to develop new drugs
to tackle the global public health crisis that multi-drug resistant
bacteria present.”

Latest figures from Public Health England show that the number of Methicillin Sensitive Staphylococcus aureus (MSSA) blood infection (bacteraemia) cases continue to rise in the UK

The very
latest data
from Public
Health England
, demonstrate that the problem of Methicillin Sensitive
Staphylococcus aureus (MSSA) bacteraemia (bacterial infections
in the blood) continues
to increase in the UK, with the total number of reported cases increasing
by 5.8% compared to the previous year
. This increase is not a one
off, with the number of reported MSSA bacteraemias having increased
every year since the mandatory surveillance of Staphylococcal infections
was extended to include MSSA bacteraemia in 2011. MSSA was added to
the existing MRSA surveillance due to both the high national total of MSSA bacteraemias,
and the observation that the strides in reducing MRSA bacteraemias had
not
also been seen
among MSSA. Whist the number of MRSA bacteraemias
has dropped since 2011, the
number of MSSA bacteraemias has increased 12% since 2011
. To understand
the importance of MSSA bacteraemias, over 92% of all bacteraemias
in the UK are now caused by MSSA rather than MRSA. Dr Bill Love, CEO
of Destiny Pharma said “These latest figures once again demonstrate
that the actions implemented to reduce MRSA infections are still proving
ineffective in dealing with infections caused by MSSA and underline
the importance of developing drugs that are equally effective against
MSSA as well as MRSA.”

Destiny Pharma participates in the launch of the Antibiotic Discovery Global Network

Destiny Pharma, a founding member of the BEAM (Biotechs from Europe innovating in Anti-Microbial resistance) Alliance , participated in the launch of the Antibiotic Discovery Global (ADG) Network at the Wellcome Trust in London on June 10th The ADG is a powerful coalition that aims to tackle the near empty antibiotic development pipeline due to the emergence of antibiotic resistance. ADG aims to provide an international knowledge base and infrastructure to support global antibiotic discovery and development, including the rejuvenation of older antibiotics for new uses. Jim O’Neill, chairman of the Review on Antimicrobial Resistance (AMR) gave the keynote speech at the launch of the ADG.